Regulatory Affairs Specialist

Job Title: Regulatory Affairs Specialist
Location: Richmond, VA (Remote)
Duration: 12 Months+

Description: Regulatory Operations & Compliance– Preclinical Logistics (PGA Focus)
Position Summary
This role leads regulatory operations and compliance for the global movement of preclinical and early-stage laboratory materials. The focus is on navigating Partner Government Agency (PGA) requirements (e.g., FDA, Fish & Wildlife, TSCA) for non-commercial materials that fall outside traditional supply chain structures. The position operates in a dynamic, evolving environment, partnering with scientific and trade compliance teams to establish frameworks, guide daily execution, and build scalable, compliant processes.
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Key Responsibilities
Regulatory Advisory & Execution
•Provide operational support for international shipments of preclinical and investigational materials
•Assess and advise on required permits, documentation, and applicable PGA regulations
•Determine appropriate resolution pathways, including escalation when necessary
•Partner with internal teams to ensure compliant import/export activities
•Address real-time shipment challenges and regulatory inquiries
•Serve as the primary regulatory advisor for non-standard shipment scenarios (lab-to-lab, sponsor-to-lab)
Process Development & Standardization
•Establish regulatory guardrails and decision-making frameworks
•Develop a comprehensive playbook outlining requirements by shipment type, agency workflows, and documentation standards
•Create repeatable processes for regulatory assessment and exception handling
•Drive consistency across teams operating without established structure
Program & Strategy Development
•Assess current regulatory processes and identify gaps
•Define and implement a roadmap to enhance regulatory operations
•Establish best practices, SOPs, and cross-functional coordination models
•Enable scalability of the regulatory compliance function
Cross-Functional Collaboration
•Collaborate with laboratory/scientific teams, global trade compliance, and internal stakeholders
•Translate complex regulatory requirements into clear operational guidance
•Provide training and ongoing support to non-regulatory personnel
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Required Qualifications
Experience
•Bach. Degree required
•5+ years in regulatory affairs, regulatory operations, or trade compliance
•Experience supporting international movement of scientific, chemical, or biological materials
•Working knowledge of PGA requirements, including FDA, Fish & Wildlife Service, TSCA, and related agencies
Technical Expertise
•Strong understanding of regulatory requirements for non-commercial or investigational materials
•Experience with cross-border compliance in life sciences
•Ability to interpret and apply regulations in ambiguous or evolving scenarios
Skills
•Proven ability to develop SOPs, playbooks, and regulatory frameworks
•Strong analytical and problem-solving capabilities
•Ability to operate effectively in unstructured environments
•Balance of strategic planning and hands-on execution
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Preferred Qualifications
•Background in chemistry, biology, or life sciences
•Experience with preclinical or clinical trial materials
•Familiarity with laboratory operations or scientific environments
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Work Environment:
•8am-5pm Eastern
•Remote work